Cleviprex Recall Expanded: More Lots Contaminated with Steel Debris

The FDA is expanding a previous Cleviprex recall to include additional lots of the hypertension drug, which are now believed to also be contaminated with stainless steel particles. The particles could reduce blood flow and lead to potentially serious injuries when injected.

The Cleviprex recall expansion was announced on March 17 by FDA. The expansion includes four additional lots of the drug, manufactured by The Medicines Company. The original recall, issued December 17, 2009, affected 11 lots of the drug.

The FDA says that the particulate matter contaminating the drug are stainless steel debris about 2.5 microns in diameter. The FDA warns that the particles could possibly reduce blood flow in capillaries, damage some tissues or cause acute allergic and inflammatory reactions. A reduction in blood flow due to the particles could also cause ischemia or organ insufficiency in the brain, kidney, liver, heart or lungs.

Cleviprex (clevidipine butyrate) is an intravenously-delivered drug used to reduce blood pressure, manufactured by The Medicines Company. The Cleviprex recall was issued after visible particles were found in vials during an annual inspection.

There have been no injuries reported in association with the contaminated Cleviprex vials.

The new lots affected by the recall are 68-407-DJ, Exp. 08/2010; 68-408-DJ, Exp. 08/2011; 71-101-DJ and 71-106-DJ, Exp. 11/2011. The previous 11 recalled lots are 61-978-DW, 61-979-DW, and 61-980-DW, Exp. 01/2010; 68-404-DJ, 68-405-DJ, and 68-406-DJ, Exp. 08/2010; 69-830-DJ, 63-385-DJ, 63-386-DJ, and 63-266-DJ, Exp 03/2011; and 64-453-DJ, Exp. 04/2011. The recall is limited to these lots.

Any health care professionals with recalled lots of Cleviprex in their inventory should return the product to the pharmaceutical distributor or wholesaler where it was purchased. The Medicines Company is currently shipping additional batches from unaffected lots to wholesalers.

Any adverse reactions from the use of Cleviprex should be reported to the FDA’s MedWatch Program at www.fda.gov/medwatch.